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Side branched endoluminal prosthesis and methods of delivery thereof

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Side branched endoluminal prosthesis and methods of delivery thereof


An expandable prosthetic device and method of delivery that allows the initial placement of multiple guidewires into selected target sites. The prosthesis includes a main body device. This main body device has a separate side branch guidewire lumen that passes through the main body device and through a side opening in the main body device. As the main body device is advanced, the side opening is self guided (by the side branch guidewire) and self-aligns to the side branch vessel ostium. The main body device is then deployed, leaving the side branch guidewire in place. A side branch device is then advanced along the side branch guidewire through the main body device, through the side wall opening and into the native side branch vessel. The side branch device can then be deployed to engage the main body device and the native side branch vessel.

USPTO Applicaton #: #20120296411 - Class: 623 112 (USPTO) - 11/22/12 - Class 623 
Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor > Arterial Prosthesis (i.e., Blood Vessel) >Stent Combined With Surgical Delivery System (e.g., Surgical Tools, Delivery Sheath, Etc.) >Expandable Stent With Constraining Means



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The Patent Description & Claims data below is from USPTO Patent Application 20120296411, Side branched endoluminal prosthesis and methods of delivery thereof.

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CROSS REFERENCE RELATED APPLICATIONS

This application is a continuation application of copending and commonly owned U.S. Ser. No. 11/739,136 filed Apr. 24, 2007.

FIELD OF THE INVENTION

The present invention relates to endoluminal prostheses and methods of delivery thereof. The endoluminal prostheses and method of delivery are particularly suited for use in bifurcated regions of body lumens.

BACKGROUND OF THE INVENTION

Stents or stent grafts are examples of expandable endoluminal prosthetic devices which are used to maintain, open or dilate stenotic lesions in body lumens or to cover and repair an aneurysm. Vascular disease may occur at a branch or bifurcation in a vessel. Placement and deployment of these prosthetic devices at bifurcations can often be problematic. One current technique is to initially deploy across an aneurysm, a main body prosthetic device having a side wall opening. The side wall opening is aligned with the side branch ostium. A second prosthetic device is then deployed through the main body prosthetic device side wall opening and into the side branch vessel. Procedural complications are often encountered while practicing this technique. These complications typically relate to the accurate placement of the main body prosthetic device and in particular to the precise alignment of the side wall opening to the native side branch vessel. Subsequent placement of the side branch guidewire through the main body prosthetic device, through the side wall opening and then into the side branch vessel can also be problematic. The deployment of the side branch prosthetic device into the native vessel can present problems relating to the longitudinal placement of the device.

Alternate procedures for treating bifurcated vessels place the guidewires prior to the device deployments. After the main body prosthetic device is deployed, it is advantageous to then remove the main body delivery catheter prior to the delivery of the side branch prosthetic device. Typical delivery systems incorporate guidewires that are contained or captured within the delivery catheter. The catheter removal therefore requires careful management of the side branch guidewire to prevent its dislodgement during the removal of the delivery catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a prosthetic device according to an aspect of the invention.

FIG. 2 is a perspective view of a catheter assembly having a removable side branch guidewire tube.

FIG. 3 is a flow chart listing the process steps used for the fabrication and delivery of a catheter assembly having a removable side branch guidewire tube.

FIG. 4 is a perspective view of an expanded main body device with first temporary tube routed through the main body lumen and a second temporary tube routed through a side branch support.

FIGS. 5A and 5B are perspective views of a compressed and constrained main body device displaying the routing of two temporary tubes.

FIG. 6A is a perspective view of a distal catheter portion.

FIG. 6B is a perspective view of a main body device compressed and constrained onto a distal catheter portion.

FIG. 7 is a perspective view of a compressed and constrained main body device with a proximal catheter portion bonded to a distal catheter portion.

FIG. 8 is a schematic diagram showing pre-placed guidewires loaded through a compressed device with a removable guidewire tube.

FIG. 9 is a schematic diagram showing a side branch guidewire routed through a removable guidewire tube.

FIG. 10 illustrates the removal of a side branch guidewire tube.

FIG. 11 is a schematic diagram showing a compressed main body device positioned at a branch vessel target site.

FIG. 12 is a perspective view of an expanded main body device having a side branch opening aligned to a side branch vessel.

FIG. 13 illustrates the initial advancement of a compressed side branch device.

FIG. 14 shows a compressed side branch device routed through the main body device and into the side branch vessel.

FIG. 15 is a perspective view of a fully deployed main body stent graft and a fully deployed side branch stent graft.

DETAILED DESCRIPTION

OF THE INVENTION

An aspect of the invention includes an expandable prosthesis comprising:

an expandable main body device having a first open end and a second open end, a wall extending from the first open end to the second open end, a lumen extending from the first open end to the second open end, and at least one side opening in the wall; and

guidewire tube having a first end, a second end and a lumen, the guidewire tube extending from at least the main body device side opening, through the main body device lumen to a point proximal to the second open end, wherein the guidewire tube is removable from the main body device while the main body device is in a compressed state.

A further aspect of the invention provides methods for delivery of an expandable prosthesis that overcome the drawbacks relating to conventional devices and delivery methods. The present invention allows for the initial placement of multiple guidewires into selected target sites. The guidewire placement is simplified since there are no endoluminal devices complicating the guidewire placement. As a failsafe, the procedure can be aborted if the guidewires cannot be properly placed. After proper placement of the guidewires is confirmed, a main body prosthetic device can be advanced to the treatment site. This main body device has a separate side branch guidewire that passes through the main body device and through the side opening in the main body device. Therefore as the main body device is advanced, the side opening is self guided (by the side branch guidewire) and self aligns to the side branch vessel ostium. The main body device is then deployed, leaving the side branch guidewire in place. The side branch guidewire is released as the main body device is deployed. The delivery catheter can then be readily removed without dislodging the placement of the side branch guidewire. A side branch prosthetic device can then be advanced along the side branch guidewire through the main body device, through the side wall opening and into the native side branch vessel. The side branch device can then be deployed to engage the main body device and the native side branch vessel.

In an aspect of the invention a side branch guidewire lumen is formed by a relatively short, removable tube. This tube preserves a lumen during the compaction and storage of the main body prosthetic device and can be simply removed after a guidewire is inserted prior to the advancement of the device into the body. The short length of the removable guidewire tube permits a single operator to back load and advance the device, similar to a conventional balloon catheter configured for “rapid exchange”.

Further understanding of the invention may be had with reference to the figures. Shown in FIG. 1 is a compressed prosthetic device according to the present invention.

The expandable prosthesis comprises:

an expandable main body device 40 having a first open end 1 and a second open end 2, a wall extending from the first open end 1 to the second open end 2, a lumen 3 extending from the first open end 1 to the second open end 2, and at least one side opening 42 in the wall; and

guidewire tube 32 having a first end 11, a second end 12 and a lumen 13, the guidewire tube 32 extending from at least the main body device side opening 42, through the main body device lumen 3 to a point proximal to the second open end 2, wherein the guidewire tube 32 is removable from the main body device 40 while the main body device 40 is in a compressed state.

The expandable main body device can be either self-expanding or balloon expandable. Typically, a self-expanding device will include at least one shape memory material, such as nitinol. The main body device can comprise a stent or stent graft. Suitable stent materials include, in addition to nitinol, for example, metallic, polymeric or natural materials and can comprise conventional medical grade materials such as nylon, polyacrylamide, polycarbonate, polyethylene, polyformaldehyde, polymethylmethacrylate, polypropylene, polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride, polyurethane, elastomeric organosilicon polymers; metals such as stainless steels, cobalt-chromium alloys and nitinol and biologically derived materials such as bovine arteries/veins, pericardium and collagen. Stents can also comprise bioresorbable materials such as poly(amino acids), poly(anhydrides), poly(caprolactones), poly(lactic/glycolic acid) polymers, poly(hydroxybutyrates) and poly(orthoesters).

The main body device can comprise a stent at either the first open end, the second open end, or at both the first open end and the second open end. Moreover, the stent can be a single stent extending from the first open end to the second open end. In an aspect of the invention, graft material is used to form the wall and extends from the first open end to the second open end. Grafts can have various configurations and can be fabricated, for example, from tubes, sheets or films formed into tubular shapes, woven or knitted fibers or ribbons or combinations thereof. Graft materials can include conventional medical grade materials such as nylon, polyester, polyethylene, polypropylene, polytetrafluoroethylene, polyurethane and elastomeric organosilicon polymers.

Stents can be used alone or in combination with graft materials. Stents can be configured on the external or internal surface of a graft or may be incorporated into the internal wall structure of a graft.

Shown in FIG. 2 is a side view of a catheter assembly 20 having a proximal catheter portion 22, a proximal hub assembly 24 and a distal catheter portion 26. The distal catheter portion 26 comprises a main body stent (or stent graft) portion 28. The main body stent is shown in a compressed state, maintained by a constraining sleeve 30. Also shown is a removable side branch guidewire tube 32.

FIG. 3 is a flow chart depicting the assembly and delivery sequence of a catheter system having a removable guidewire tube. Following are details relating to the steps listed on flowchart FIG. 3:

Step 1) Place Expanded Main-Body Device onto First Temporary Tube.

Shown in FIG. 4 is an expanded main body stent graft 40 having a side wall opening 42 and an internal side branch support channel 44. A first temporary tube 37 can be inserted through the stent graft main body lumen. A first stiffening mandrel 39 can be positioned within the first temporary tube. The stent graft can be fabricated, for example, according to the methods and materials as generally disclosed in U.S. Pat. Nos. 6,042,605; 6,361,637; and 6,520,986 all to Martin et al. Details relating to exemplary fabrication and materials used for internal side branch support channel 44 can be found in U.S. Pat. No. 6,645,242 to Quinn.

Step 2) Place Second Temporary Tube Through Side Branch Support.

Referring to FIG. 4, a second temporary tube 41 can be routed through the side wall opening 42 and through the internal side branch support channel 44 to the second open end 2 of stent 40.

Step 3) Compress Main Body, Add Constraining Sheath

Referring to FIG. 5A, the main body stent can be compressed and held in the compressed state by a constraining sleeve 30. The sheath can be laced together by a deployment cord 46. The sheath lacing forms a generally longitudinal seam along the constraining sheath. The constraining sheath can be provided with a slit 43 that is oriented perpendicular to the longitudinal seam 46. The slit can subsequently provide an exit point for the second temporary tube 41. Additionally, the second temporary tube 41 could exit through the stitch line. Details relating to constraining sheath materials, sheath methods of manufacture and main body compression techniques can be found in, for example, U.S. Pat. Nos. 6,352,561 to Leopold et al., and 6,551,350 to Thornton et al.

Step 4) Route Distal End of Second Temporary Tube Through Slit in Constraining Sheath.

As shown in FIG. 5B, the second temporary tube 41 can be routed through the slit 43. A small spring puller or hook can be inserted through the slit and used to engage the lumen of the second temporary tube. Once the lumen is engaged the second tube can be pulled through the slit as shown in FIG. 5B. After the second temporary tube 41 is routed through the constraining sheath, a second stiffening mandrel 49 can be inserted through the second temporary tube.

Step 5) Remove First Temporary Tube and Replace with Distal Catheter Portion.

Shown in FIG. 6A is distal catheter portion 26 having a distal tip 45 and a shaft 47. The distal catheter portion 26 has a continuous lumen 36 that is sized to accommodate a guidewire. As shown in FIG. 6B, the first temporary tube can be replaced by the distal catheter portion 26. The first temporary tube 37 can be removed by placing the lumen 36 of the catheter shaft 47 onto the stiffening mandrel 39. The distal catheter portion 26 can then be used to push the first temporary tube out of the compressed device. After the catheter portion is fully inserted, the stiffening mandrel 39 can be removed.

Step 6) Bond Proximal Catheter Portion to Distal Catheter Portion.

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Previous Patent Application:
Methods of implanting a prosthesis
Next Patent Application:
Stent delivery system
Industry Class:
Prosthesis (i.e., artificial body members), parts thereof, or aids and accessories therefor
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stats Patent Info
Application #
US 20120296411 A1
Publish Date
11/22/2012
Document #
13562200
File Date
07/30/2012
USPTO Class
623/112
Other USPTO Classes
International Class
61F2/84
Drawings
15



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